Status  Report:       Implementation  of  Enhancements  to  Human  Research  Protections     at  the  University  of  Minnesota     David  H.  Strauss,  M.D.   August  2016    

 

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  At  the  request  of  Dr.  Brian  Herman,  Vice  President  for  Research  at  the  University  of  Minnesota,   I  offer  the  following  observations  and  recommendations  on  the  University’s  response  to  the   February  2015  External  Review  of  its  human  subjects  protections  program.  This  report  draws   upon  discussions  with  members  of  the  university  community  during  my  visit  in  late  March;   telephone  and  in-­‐person  meetings  with  faculty  and  staff  prior  to  and  subsequent  to  the  visit;   and  review  of  available  draft  and  final  reports  and  documents  related  to  the  University’s  efforts   to  fulfill  its  commitment  to  human  subjects  protections.     In  response  to  the  recommendations  of  the  External  Review,  the  University  has  set  a  course  to   re-­‐establish  and  re-­‐invigorate  its  human  research  protections  program.    The  call  for  change  has   been  fully  embraced  by  the  University  and  the  effort  reflects  extraordinary  resolve,  effective   leadership,  and  teamwork  at  many  levels.  Progress  to  date  has  been  impressive,  but  the  success   of  Advancing  Human  Research  Protections  will  be  measured  over  years  and  will  require  ongoing   commitment  and  refinement  of  newly  implemented  structures,  policies  and  practices.       Background     In  July  2014,  University’s  Faculty  Senate  commissioned  an  external  review  to  address   continuing  criticism  of  the  human  subjects  protections  program  at  the  University  of  Minnesota,   including  concerns  raised  by  its  own  faculty  and  staff.    In  response,  University  leadership   contracted  with  the  American  Association  of  Accreditation  of  Human  Research  Protections   Program  to  hire  a  team  of  external  reviewers  to  examine  the  current  state  of  policies,   procedures  and  practices  related  to  human  subjects  protections,  with  special  attention  to   research  participants  with  impaired  decision-­‐making  capacity.       In  February  2015,  the  external  review  team  provided  a  report  of  its  findings  and   recommendations  (hereafter,  the    “the  External  Review,”  or  “The  Report”).    The  Report  was   widely  critical  of  University  practices,  and  identified  both  fundamental  shortcomings  and   missed  opportunities  requiring  attention  if  the  University  was  to  satisfy  its  critics  and  achieve  its   stated  goal  of  establishing  a  clinical  research  enterprise  that  met  or  surpassed  best  practices.         In  response,  in  April  2015,  the  University  convened  an  Implementation  Team  whose   June  2015  work  plan  “Recommendations  of  the  External  Review  of  the  University  of   Minnesota  Human  Research”  outlined  a  university-­‐wide  effort  and  an  18-­‐month   timeline  to  remake  its  human  subjects  protection  program  and  establish  its   commitment  to  high  ethical  standards  in  clinical  research.  To  support  and  guide  the    

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effort  under  the  umbrella  term,  “Advancing  Human  Research  Protections,”  the  Office  of   the  Vice  President  for  Research  established  a  standing  Research  Compliance  Advisory   Committee  (RCAC).  The  university  designed  and  launched  this  effort  and  component   processes  (e.g.  “IRB  Renew”)  with  broad  input  and  representation.         In  keeping  with  its  commitment  to  transparency,  all  plans,  work  products  and  meeting   summaries  were  made  available  to  the  public.    Descriptions  of  progress  toward  fulfilling   each  of  the  objectives  of  the  Work  Plan  are  well  catalogued  in  easily  accessible   documents  on  web  pages  dedicated  to  this  now  14-­‐month  long  effort.     The  recommendations  of  the  External  Review  were  numerous,  broad  in  scope,  and   emphasized  six  overlapping  and  interrelated  problem  areas.    These  categories  form  the   structure  of  the  report  that  follows:     I. The  involvement  by  university,  medical  school,  and  hospital  leadership  in  human   research  protections     II. The  quality  of  IRB  review     III. Education  and  training  of  investigators  in  research  ethics  and  research  subject   protections   IV. Policies  and  practices  related  to  informed  consent  and  the  inclusion  of  research   subjects  with  impairment  in  consent  capacity   V. Research  within  the  Department  of  Psychiatry   VI. University  culture  and  values        

 

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I.  The  Involvement  by  University,  Medical  School,  Hospital  and  Departmental   Leadership  in  Human  Research  Protection  Program     A  central  conclusion  of  the  External  Review  was  that  leadership  at  the  University,  the  Academic   Health  Center,  and  at  the  department  level  was  not  sufficiently  engaged  in  the  activities  and   mission  of  human  research  protections.    For  example,  the  report  noted,  “The  University  and  its   Medical  School  do  not  appear  to  employ  existing  lines  of  reporting  to  define  a  hierarchy  of   accountability  for  human  research  ethics  [in  order  to]  expand  oversight  responsibilities  beyond   the  IRB.”     Observations:     University  leadership  has  embraced  the  many  recommendations  of  the  External  Review  with   extraordinary  resolve  and  energy.      The  development,  implementation,  and  success  to  date  of   the  Advancing  Research  Protections  initiative  itself  derive  from  a  new  and  vitally  important   degree  of  involvement  by  leadership.       The  creation  of  a  central  Research  Compliance  Office,  the  development  of  a  Community   Oversight  Board,  and  the  introduction  of  a  Fairview  University  Research  Oversight   Committee  (FUROC)  represent  three  important  new  structures  central  to  the  effort.     The  March  2016  “Hierarchy  of  Accountability”  specifically  defines  the  larger  network  of   interrelated  committees,  programs,  and  reporting  relationships  focused  on  human   research  protections.    The  “Fairview  Research  Administration  (FRA)  Chain  of  Command”   (Appendix)  illustrates  the  integration  and  coordination  of  institutional  research   oversight  responsibilities.     The  External  Review  called  for  the  involvement  of  Fairview  staff  in  “gatekeeping”  functions  to   ensure  that  clinical  interests  remain  priorities  in  research  in  the  hospital  setting.    The  FUROC  is   co-­‐chaired  by  Fairview’s  Interim  Chief  Medical  Officer  and  the  VP  for  Health  Sciences,  and   includes  the  University’s  VP  for  research  and  the  Chief  Nursing  Executive  of  M  Health,  among   others.      According  to  a  summary  of  its  charge,  FUROC  will:     …serve  as  a  place  for  researchers,  staff,  and  the  public  to  share  concerns  and  to  achieve   a  response  or  resolution  to  those  concerns.  The  committee  is  to  monitor  the  entire   spectrum  of  clinical  research  across  the  Fairview  Health  System  to  insure…both  research   and  clinical  regulatory  obligations  are  met…research  protocols  are  appropriate  and    

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feasible  within  the  concurrent  demands  of  patient  care  [and]  that  Fairview  staff   members  have  a  voice  in  the  conduct  of  research.”       A  new  practice,  under  the  direction  of  FUROC,  now  requires  the  involvement  of   leadership  and  line  clinical  staff  in  the  process  of  research  protocol  development,   implementation,  and  ongoing  monitoring.    The  Clinical  Research  Study  -­‐Fairview   Behavioral  Service  Checklist  (Appendix)  outlines  this  requirement  and  documents  its   fulfillment.  “Climate”  assessments  are  planned  and  will  help  leadership  gauge  the   impact  of  these  new  oversight  efforts.       The  Community  Oversight  Board,  with  whom  I  had  the  opportunity  to  meet,  includes  a  diversity   of  expertise,  interests  and  constituencies  from  within  and  outside  the  University.    The  group   demonstrated  enormous  enthusiasm  and  recognized  its  potential  to  serve  both  consultative   and  oversight  functions  with  regard  to  human  research  protections  and  research  ethics  more   broadly.    There  is  evidence  of  bidirectional  communication;  the  IRB  has  presented  to  the  COB,   and  the  COB  has  offered  input  on  the  Research  Subject  Bill  of  Rights.    However,  the  stated     desire  by  members  of  the  COB  to  understand  their  role  was  the  topic  of  much  of  the  discussion   during  my  meeting  with  the  group.    Many  members  seemed  uncertain  of  their  responsibilities,   their  access  to  information  about  research  practices,  and  whether  they  were  to  be  “responsive   or  proactive.”     The  University  has  taken  a  valuable  step,  also  referenced  in  the  External  Review,  to   draw  upon  the  strengths  of  its  highly  regarded  academic  programs.    Linkages  between   University  compliance  functions,  the  Consortium  on  Law  and  Values,  and  the  Center  for   Bioethics  have  already  enriched  activities  such  as  educational  programming  and  the   development  of  a  statement  of  core  commitments.         The  External  Review  called  for  the  involvement  of  department  level  leadership  in   research  oversight  functions.    The  Departments  of  Psychiatry  and  Neurology  have  been   working  with  the  IRB  to  develop  educational  programming;  the  IRB  anticipates  more   widespread  participation  by  the  departments  in  this  work.    However,  the  Medical  School   has  yet  to  specify  a  role  for  department  chairs  in  supporting  routine  compliance   activities  (or  where  they  sit  within  the  Hierarchy  of  Accountability).       At  the  time  of  my  visit  in  March,  some  roles  and  responsibilities  within  the  nascent   oversight  hierarchy  remained  only  partially  defined,  as  did  the  relationships  and   boundaries  between  others.      One  member  of  the  RPAC  was  critical  of  the  purpose  and    

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uncertain  of  the  responsibilities  of  this  steering  committee.    Elsewhere,  concerns  were   expressed  with  regard  to  the  relative  roles  and  responsibilities  of  the  Research   Compliance  Office,  the  CTSI,  and  the  IRB.         What  is  not  evident  from  document  review  and  web-­‐browsing,  however,  but  became   immediately  apparent  during  my  visit  to  the  University,  was  the  degree  of  involvement   by  senior  leadership  of  the  University  and  Health  Sciences  Center,  the  vast  number  of   faculty  and  staff  of  all  disciplines  engaged  in  the  work  of  implementation,  and  the   commitment  and  enthusiasm  they  brought  to  the  work.      The  IRB  leadership,  with  whom   I  had  the  opportunity  to  spend  several  hours,  expressed  pride  in  the  evolving  changes  in   their  operation  and  optimism  about  what  they  hoped  to  achieve  with  the  additional   support  and  resources  made  available  to  them  by  the  University.         Discussion:     Under  the  direction  of  University  leadership,  the  University  has  conceived  and  crafted   an  impressive  infrastructure  with  the  potential  to  drive  and  sustain  meaningful  progress   in  human  research  protection.    It  is  substantially  responsive  to  the  External  Review.       Rapid  change  of  the  sort  required  of  the  Work  Plan  will  almost  certainly  be  associated   with  missteps  and  require  some  reanalysis.    The  need  for  course  corrections  and   iterative  refinements  should  be  anticipated,  encouraged,  and  carefully  guided  by   leadership  as  it  prepares  to  transition  from  implementation  to  maintenance  and   assessment  phase.         The  Community  Oversight  Board  can  mature  to  assume  multiple  roles  on  behalf  of  the   HRPP,  and  its  membership  should  work  with  leadership  to  define  how  its  relationships   within  and  outside  the  University  can  best  support  and  shape  the  University’s  vision  of   ethical  research,  patient/subject  and  family  engagement,  and  research  advocacy.    As  a   semi-­‐independent  body,  the  COB  can  provide  a  non-­‐institutional  perspective  on  policy   matters  of  importance  to  the  University.    In  its  oversight  function,  it  can  promote   accountability  to  subject  and  community  interests  and  influence  practice.           The  Fairview  University  Research  Oversight  Committee  bridges  a  wide  gap  that  existed   between  clinical  care  and  research  functions  at  Fairview.    It  supports  a  vital  interaction   that  can  promote  joint  responsibility  between  hospital-­‐based  clinical  functions  and   University  research.    While  I  did  not  meet  with  representatives  of  Fairview,  summaries    

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of  FUROC  meetings  describe  a  plan  to  become  actively  engaged  in  the  review  of  policies,   monitoring  findings  and  event  reports.    FUROC  will  periodically  assess  the  effectiveness   of  Fairview’s  efforts  to  promote  “gatekeeping”  functions  by  its  clinical  teams.     The  External  Review  emphasized  the  value  of  Departmental  accountability  for  compliance   activities,  and  with  some  exceptions,  this  does  not  appear  to  be  central  to  the  implementation   plan.  Department  heads  involved  in  matters  such  as  setting  compensation,  evaluating  effort,   supporting  faculty  for  academic  promotion,  and  otherwise  assessing  the  state  of  departmental   activity,  are  uniquely  positioned  to  support  the  University’s  educational  and  compliance   agenda,  and  do  so  in  manner  that  is  tailored  to  the  nature  of  the  work  of  the  department  and   the  investigator.    Department  chairs  should  be  aware  of  compliance  problems  within  their   service  area  or  among  their  faculty.    They  can  play  a  valuable  role  in  enforcing  IRB  rules  and   identifying  “local”  solutions  to  the  non-­‐compliant  investigator.  The  external  review  noted,  “the   Dean  of  the  medical  school  could  craft  policies  requiring  the  departments  to  develop  ethics   education  requirements  and  content,  build  relevant  performance  metrics  into  investigator   evaluations,  and  most  importantly,  hold  chairs  accountable  for  human  subjects  protections   within  their  departments.”                  

 

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II.  The  Quality  of  IRB  Review       The  External  Review  identified  problems  with  the  quality  of  IRB  review  and  with  the   value  of  a  department-­‐based  scientific  review  process.    The  examination  of  IRB   membership  rosters  and  meeting  attendance  raised  concerns  about  reviewer  expertise   and  workload,  and  IRB  documentation  suggested  that  IRB  deliberations  lacked   necessary  substance.    The  extent  of  involvement  of  IRB  leadership  in  investigations  of   non-­‐compliance  was  seen  as  an  unnecessary  additional  burden  on  the  operation.       Observations:     In  response  to  the  External  Review,  the  University  developed  an  ambitious  plan  to   reform  its  IRB  operations  and  IRB  review  processes.    The  University  engaged  internal   and  external  consultants,  examined  other  nationally  recognized  University  programs,   and  committed  significant  new  funding  to  support  system-­‐wide  change.         The  IRB  leadership  team,  with  whom  I  had  the  opportunity  to  spend  considerable  time,   is  a  talented  and  highly  professional  group  with  great  pride  in  its  work  and  commitment   to  excellence  in  human  research  protections.         An  analysis  of  the  scope  and  content  of  the  University’s  human  subjects  research   portfolio  was  used  to  estimate  demand  for  review  and  categories  of  required  reviewer   expertise  in  order  to  plan  for  a  restructured  IRB  committee  process.  Implementation  of   the  plan  was  slowed,  however,  by  difficulty  in  recruiting  new  IRB  members;  feedback   indicated  that  the  planned  meeting  schedule  would  place  excessive  demands  on  faculty   time.    With  the  input  of  external  consultants,  the  University  made  a  prudent  mid-­‐course   correction  in  the  design  and  timeline  for  the  new  IRB  committee  structure.    At  the  12-­‐ month  mark,  new  IRB  members  have  been  identified,  oriented,  and  trained.    Four  of  8   planned  panels  commenced  or  will  soon  commence  review.           In  the  interim,  the  IRB  review  process  has  undergone  considerable  refinement.     Important  changes  include  the  addition  of  meetings  so  that  there  is  now  a  single   Continuing  Review  and  a  single  Biomedical  IRB  meeting  each  week,  a  capping  of  the   number  of  items  that  can  be  addressed  at  any  meeting,  and  a  review  format  that   demands  a  more  structured  and  systematic  evaluation  of  each  research  proposal.    

 

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The  University  has  contracted  with  Huron  consulting,  and  has  begun  to  make  use  of  the   Huron  Toolkit  that  provides  forms,  templates,  and  checklists  to  facilitate  review,  and   supports  training  of  both  IRB  staff  and  reviewers  on  standard  operating  procedures.    For   example,  a  checklist  prompts  IRB  administrators  to  assess  and  document  whether  the   required  number  of  reviewers  is  present  and  whether  reviewers  with  appropriate   expertise  are  present  at  the  IRB  meeting.    With  this,  and  with  enhanced  staffing,  IRB   professionals  plan  to  conduct  a  more  robust  administrative  and  regulatory  pre-­‐review  of   research,  thereby  facilitating  a  more  focused  committee  review.       The  University  has  outsourced  IRB  Review  of  industry-­‐sponsored  research  in  the   Department  of  Psychiatry  to  a  highly  regarded  independent  (commercial)  review  board,   Quorum  Review.         The  University  has  allocated  funds  to  pay  IRB  members,  augment  members’  salaries,  or   offset  departmental  contributions  to  salary.    Other  methods  of  providing  incentives  or   requirements  are  currently  being  examined.       Responsibility  for  for-­‐cause  monitoring  has  shifted  to  the  RCO.    At  the  time  of  my  last   meeting  with  IRB,  the  respective  roles  for  the  CTSI,  the  RCO,  and  the  IRB  required   clarification.     The  External  Review  was  critical  of  the  existing  department-­‐based  scientific  review  of   human  subject  research  protocols:  there  was  little  evidence  that  the  process  was   substantive,  and  in  some  departments,  it  was  likely  to  be  influenced  by  bias  or   conflicting  interests.    Also,  scientific  review  was  not  considered  by  the  IRB  in  its   deliberations.  As  part  of  the  Work  Plan,  department-­‐based  scientific  review  has  been   eliminated  and  replaced  by  an  online  process  of  review  by  scientifically  qualified  IRB   members.      The  process  requires  two  reviewers  to  make  a  determination  based  on  two   broad  questions:       (1) Is  the  scientific  question  reasonable?     (2) Will  the  methods  described  in  the  protocol  answer  that  question?       Several  “sub-­‐criteria,”  such  as  “the  research  has  the  potential  to  provide  new  and  useful   knowledge,”  and  “the  principal  investigator  is  qualified  to  conduct  the  research,”  are   intended  to  assist  in  the  categorical  decision  to  “Accept”  the  protocol  for  IRB  review  or   “Do  Not  Accept.”  Both  reviewers  must  “Accept”  for  the  protocol  to  be  forwarded  for  IRB    

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submission.      No  other  information  about  the  reviewer’s  assessment  is  provided  to  the   IRB.    A  “Do  Not  Accept”  decision  requires  the  reviewer  to  solicit  additional  information   from  the  researcher.         Plans  are  underway  to  introduce  a  new  electronic  IRB  submission  tool  by  Spring   2017.     Discussion:     The  University  has  made  a  substantial  material  and  intellectual  investment  in  the  structure  and   function  of  the  IRB.    Interim  measures  to  increase  the  number  of  meetings,  limit  reviewer  work-­‐ load,  and  to  better  structure  deliberations,  address  key  concerns  raised  by  the  External  Review   and  represent  important  accomplishments.    New  approaches  to  member  training,  the  addition   of  members  and  panels,  and  the  introduction  of  a  toolkit  to  promote  a  more  effective  review   process  all  represent  a  significant  re-­‐making  of  IRB  review.         Ongoing  attention  to  the  outcome  and  effectiveness  of  these  operational  improvements  is   essential;  regular  measurement  of  IRB  adherence  to  quality  is  planned.    While  the  University’s   effort  to  remake  its  IRB  process  is  well  underway,  success  will  require  ongoing  refinement  of   policies  and  procedures  in  response  to  performance  measures.    The  University  plans  an  annual   assessment  of  IRB  operations.         It  is  not  surprising  that  the  recruitment  of  new  IRB  members  has  been  slow  and  difficult.     Increased  willingness  to  serve  on  the  IRB  may  occur  as  the  new  cohort  of  reviewers  report  back   on  their  experience  within  an  enhanced  IRB  operation.  The  University  and  Academic  Health   Center  should  continue  to  identify  financial  and  academic  incentives  for  IRB  participation,  and   gauge  satisfaction  among  new  member  in  terms  of  training,  workload,  and  efficiency.    Finally,  a   requirement  for  research  departments  to  have  representation  on  the  IRB  in  proportion  to  the   size  of  their  research  portfolio  is  not  unreasonable.         The  University  has  eliminated  department-­‐based  scientific  review,  but  it  is  not  clear  if  this  new   approach  offers  advantages  over  scientific  review  that  is  conducted  by  the  IRB  itself.    It  is  also   not  clear,  in  the  new  approach,  if  the  IRB  is  expected  to  conduct  its  own  assessment  of  study   merit.    Approval  criteria  require  an  IRB  to  determine  whether  “risks  to  subjects  are  reasonable   in  relation  to  anticipated  benefits  to  subjects,  if  any,  and  the  importance  of  the  knowledge  that   may  reasonably  be  expected  to  result.”  The  categorical  determination  of  merit  (Accept  vs  Do   Not  Accept)  under  the  current  practice  will  provide  the  IRB  with  no  meaningful  information    

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about  the  reviewer’s  assessment  of  study  benefit.    For  example,  the  current  method  may  not   serve  to  address  concerns  about  an  industry-­‐sponsored  study  of  a  “me  too  drug”  which  is   scientifically  sound,  but  adds  little  “new  knowledge”  and  therefore  may  not  justify  risks  to   subjects.    Also,  absent  benchmarks  or  anchors  for  decision-­‐making,  how  will  a  categorical   Accept/Do  Not  Accept”  choice  be  made?  A  default  mode  for  all  but  the  most  concerning   research  may  well  be  “Accept.”      To  promote  a  more  substantive  review,  the  University  should   consider  requiring  reviewers  to  comment  and  rate  each  criterion  and  to  “Accept  with   comments.”    If  unchanged,  the  process  should  be  tracked  and  its  value  and  validity  assessed.     Expectations  for  review  of  merit  by  the  IRB  should  be  defined  in  policy.     The  implementation  of  the  NIH  policy  on  the  use  of  single  IRBs  in  multicenter  research  in  2017,   like  the  anticipated  publication  of  a  revised  Common  Rule  later  this  year,  will  introduce  new   requirements  and  place  new  demands  on  the  development  of  institutional  and  IRB  policies  and   procedures.    The  completion  of  the  implementation  timeline  and  transition  to  a  “maintenance”   phase,  and  the  introduction  of  the  electronic  IRB  submission  system  at  the  University  will  also   occur  in  at  the  same  time;  these  may  well  place  strain  on  both  the  IRB  and  researcher   communities.      Advanced  planning  is  warranted.                

 

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III.  Education  and  Training  of  Investigators  and  Staff       The  External  Review  stated,  “The  broader  educational  policies  and  practices  at  the   University  fulfill  minimal  standards  but  represent  a  missed  opportunity  for  a  richer  and   more  sophisticated  institute-­‐wide  approach  to  investigator  training.”         Online  “ethics  training”  under  the  auspices  of  the  Collaborative  Institutional  Training  Initiative   (CITI)  has  become  a  standard  human  subjects  protection  and  good  clinical  practice  educational   requirement  for  universities  and  other  clinical  research  enterprises  nationwide.    The  extent  to   which  CITI  provides  effective  training,  however,  is  not  known.    Given  the  nature  of  the  problems   identified,  the  External  Review  suggested  that  the  University  would  benefit  from  advanced  and   specific  educational  opportunities  and  requirements,  particularly  in  relation  to  matters   involving  informed  consent  and  the  inclusion  of  vulnerable  populations  in  research.       Observations:     The  University  engaged  an  external  educational  consultant  to  evaluate  its  human   subjects  training  activities  and  evaluate  these  against  standards  and  national  norms.     Based  on  this  assessment  and  its  priority  recommendations,  the  Education  and  Training   Work  Group  (Appendix)  concluded:         …  that  the  University  of  Minnesota  strengthen  the  current  knowledge-­‐based   human  research  protection  training  and  work  to  develop,  assess  and  implement   skill  and  attitude-­‐based  training  over  the  next  three  years.  The  resulting  training   program  should  be  comprised  of  a  hybrid  of  online,  discussion,  peer  learning,   case  and  simulation,  problem-­‐solving  practice,  learning  assessment,  and   demonstration  of  competence.  The  training  needs  to  insure  the  appropriate   levels  of  training  for  the  specific  research  being  performed  and  that  human   subjects  are  appropriately  protected.  Simultaneously  the  training  must  be  high   quality  and  the  potential  burdens  for  investigators  and  staff  to  understand,   obtain  and  remain  compliant  with  the  required  training  should  be  minimized.   Advanced  training  should  be  strongly  encouraged,  supported  and  rewarded.     The  planned  introduction  of  a  range  of  learning  formats-­‐-­‐“skill  and  attitude-­‐based”   training,  “learner  assessment,”  as  well  as  ongoing  program  evaluation”-­‐-­‐reflects  a   significant  commitment  to  meaningful  education  in  human  research  protections  and  will   doubtless  place  the  University  in  the  forefront  of  such  efforts.        

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  Plans  to  develop  and  pilot  advanced  training  for  researchers  working  with  vulnerable   individuals  and  those  with  diminished  capacity,  and  to  pilot  consent  training  programs  in   the  Department  of  Psychiatry,  represent  a  joint  effort  by  the  CTSI,  IRB  and  the  Center   for  Bioethics.       Other  enhancements  involve:  the  hiring  of  an  IRB  education  and  outreach  specialist;     monthly  IRB  newsletters  and  HRPP  Education  and  Outreach  reports  for  the  research   community;  course  offerings  from  the  Center  for  Bioethics;  day-­‐long  conferences  on   ethics  and  research  protections;  video-­‐training  opportunities;  and     new  educational  toolkits  for  study  coordinators.     Discussion:     CITI  training  has  become  the  national  standard  because  it  is  inexpensive,  scalable,  and   trackable.    However,  most  agree  it  offers  little  more  than  “lip-­‐service”  to  the  notion  of   ethics  training,  at  least  there  is  no  data  to  suggest  otherwise.    How  best  to  educate  and   sensitize  researchers  is  ultimately  an  empirical  question.    Given  the  many  groups   contributing  to  training  initiatives  at  the  University,  a  central  infrastructure  or   “clearinghouse”  for  education  could  offer  a  promising  model  for  the  coordination  and   study  of  education  and  training.      The  extent  to  which  individual  research  departments   and  centers  can  be  assisted  in  developing  their  own  educational  programming  should  be   explored,  as  should  “train-­‐the-­‐trainer”  efforts.     Tailoring  educational  programming  to  the  learning  needs  of  researchers  in  different   disciplines  and  assessing  competencies  and  skills  will  represent  a  leap  forward  for  the   University  and  for  the  field.  However,  substantial  effort  and  funding  will  be  required  to   develop  and  fully  implement  the  education  and  training  program  envisioned  in  the   Work  Plan.    The  University  is  prudent  to  focus  implementation  on  priority  areas   (enhancing  the  consent  process,  assessing  capacity  in  vulnerable  populations,   identifying  and  minimizing  risks  in  research)  with  active  and  iterative  modification   before  larger  scale  roll-­‐out.    This  may  shift  the  implementation  timeline,  but  will   ultimate  prove  more  effective.     Regardless  of  quality,  educational  opportunities  such  as  the  March  2016  lecture  on   consent  for  study  coordinators  (also  available  online)  or  the  15-­‐week  lecture  series   “Standards  for  Research  with  Human  Subjects”  are  not  likely  to  attract  the  desired    

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audience  and  may  serve  only  to  “preach  to  the  converted.”    The  University  should   mandate  training  beyond  CITI  for  IRB  members  and  all  those  involved  in  human  subjects   research.          

 

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  IV.  Policies  and  practices  related  to  informed  consent  to  research  and  the  inclusion  of  

research  subjects  with  impairment  in  consent  capacity     The  External  Review  offered  an  extensive  analysis  and  a  series  of  recommendations   related  to  the  process  of  informed  consent,  the  assessment  of  capacity,  and  safeguards   related  to  the  enrollment  of  research  subjects  with  impaired  decision-­‐making.         Observations:     With  regard  to  the  inclusion  of  subjects  with  impaired  consent  capacity  or  those  who     lack  the  capacity  to  consent,  the  University  introduced  two  important  additions  to  the   Policy  and  procedure  manual,  both  dated  March  2016.    Entitled  Adults  Lacking  Capacity   and/or  Adults  with  Diminished  Capacity  to  Consent  and  Vulnerable  Populations  these   additions  established  new  standards  for  IRB  review  and,  therefore,  for  research  protocol   design.    In  August,  these  policies  were  superseded  by  new  policies,  and  associated  IRB   reviewer  Checklists  and  investigator  Standard  Operating  Procedures  (SOPs)  were  added.     The  SOP  entitled  “Informed  Consent  Process  for  Research”  provides  step-­‐by-­‐step  “instructions”   on  consent  for  the  investigator.    While  rudimentary,  the  SOP  does  establish  certain  guidelines   to  foster  informed  decision-­‐making.    For  example,  1.1  to  1.3  (below)  prompt  the  investigator  to   invite  the  subject’s  questions  and  to  allow  the  subject  time  to  consider  consent  or  confer  with   others  before  making  a  decision.    Item  1.4  establishes  an  expectation  that  subject   understanding  should  be  assessed  in  all  circumstances  by  the  researcher.         1.1

Invite  and  answer  the  subject/representative’s  questions.  

1.2

Give  the  subject/representative  time  to  discuss  taking  part  in  the  research  study  with   family  members,  friends  and  other  care  providers  as  appropriate.  

1.3

Invite  and  encourage  the  subject/representative  to  take  the  written  information   home  to  consider  the  information  and  discuss  the  decision  with  family  members  and   others  before  making  a  decision.  

1.4

Ask  the  subject/representative  questions  to  determine  whether  all  of  the  following   are  true,  and  if  not,  either  continue  the  explanation  or  determine  that  the   subject/representative  is  incapable  of  consent:   1.4.1

 

The  subject/representative  understands  the  information  provided.  

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1.4.2

The  subject/representative  does  not  feel  pressured  by  time  or  other  factors   to  make  a  decision.  

1.4.3

The  subject/representative  understands  that  there  is  a  voluntary  choice  to   make.  

1.4.4

The  subject/representative  is  capable  of  making  and  communicating  an   informed  choice.  

    The  IRB  reviewer  checklist  entitled  “Vulnerable  Populations”  prompts  an  IRB  reviewer  to   consider  a  limited  range  of  “additional  safeguards”  such  as  “Exclusion  of  the  population  if  not   required  to  achieve  study  objectives”  and  “Researcher  should  not  have  any  role  in  decisions   impacting  subjects’  status  (e.g.  institutionalization).”     The  policy  entitled  “Research  Involving  Adults  With  Absent,  Diminished,  or  Fluctuating  Capacity   to  Consent  to  Participate  in  Research”  defines  consent  capacity  and  some  general  categories  of   disorders  in  which  it  may  occur.    This  policy  establishes  the  new  requirement  to  use  a  standard   instrument  in  the  assessment  of  capacity:     The  IRB  recommends  that  the  following  validated  tools  be  used  to  evaluate  capacity  to   consent  in  research  studies  that  involve  adults  with  absent,  diminished,  or  fluctuating   capacity  to  consent:     • For  greater  than  minimal  risk  research,  the  MacArthur  Competence  Assessment  Tool  for   Clinical  Research  (MacCAT-­‐CR)  appropriate  to  the  context  of  the  research.   • For  minimal  risk  research,  a  version  of  the  UCSD  Brief  Assessment  of  Capacity  to   Consent  (UBACC)  appropriate  to  the  context  of  the  research.     This  policy  references  the  checklist  entitled  “Cognitively  Impaired  Adults”  which  specifies  the   IRB’s  approval  criteria  for  research  that  involves  adults  with  absent,  diminished,  or  fluctuating   capacity  to  consent.    It  also  references  the  SOPs  entitled  “Legally  Authorized  Representatives,   Children,  and  Guardians,”  “Informed  Consent  Process  for  Research,”  and  “Written   Documentation  of  Consent”  for  detailed  information  regarding  who  can  serve  as  an  LAR  and   the  process  for  obtaining  and  documenting  informed  consent  from  an  LAR  for  subjects  unable   to  consent.       .  

 

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The  same  policy  establishes  a  requirement  regarding  subjects  with  fluctuating  capacity  to   consent:     “The  IRB  expects  that  investigators  include  procedures  to  address  fluctuating  capacity,   where  applicable.  Where  fluctuating  capacity  to  consent  is  anticipated  in  a  subject   population,  the  protocol  must  include  plans  for  monitoring  capacity  for  the  duration  of   the  study.  “     The  policy  references  the  Checklist  “Cognitively  Impaired  Adults”  for  the  IRB’s  approval  criteria   for  research  that  involves  adults  with  fluctuating  capacity  to  consent  and  the  SOP  “Informed   Consent  Process  for  Research”  for  the  process  for  obtaining  informed  consent  from  subjects   with  fluctuating  capacity  to  consent.     The  checklist  “Cognitively  Impaired  Adults”  establishes  approval  criteria  for  research   with  subjects  who  “are  cognitively  impaired,”  and  although  not  explicitly  defined,     appears  to  mean  cognitively  impaired  subjects  “who  have  been  judged  to  lack  the   capacity  to  consent.”    Approval  of  greater  than  minimal  risk  research  is  only  allowable   when  there  is  anticipated  direct  benefit  to  the  subject,  and  includes  additional   safeguards,  such  as  “Subjects  will  be  withdrawn  if  they  appear  to  be  unduly  distressed.”       The  Policy  Research  Involving  Adults  under  Court  Jurisdiction  specifies:       “researchers  may  not  recruit  or  enroll  the  following  persons  in  any  clinical  drug  trial   under  Minnesota  law  (effective  August  1,  2016)  and/or  existing  IRB  Policy:  1)  individuals   subject  to  a  commitment  petition;  and/or  2)  individuals  temporarily  confined   involuntarily  under:  a)  72-­‐hour  emergency  admission  holds;  b)  “intent  to  leave”  periods;   or  c)  peace  officer/health  officer  authority  (formerly  “transport  hold”)  or  a  court   apprehend  and  hold  order.       Further,       “an  individual  who  has  had  a  commitment  hearing,  and  is  released  by  the  court  before  a   commitment  order  is  issued,  is  prohibited  from  participating  in  a  psychiatric  clinical  drug   trial  during  the  period  of  a  stay  of  commitment,  unless  the  court  specifically  authorizes   the  participation.  Investigators  wishing  to  recruit  such  individuals  must  provide   justification  for  doing  do  and  a  process  compliant  with  the  terms  of  the  statute.      

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In  addition,  no  member  of  a  study  team  may  participate  in  a  decision  to  rescind  or   discontinue  a  patient’s  involuntary  status  (as  described  above)  before  its  expiration,   provisionally  discharge  a  committed  patient,  or  rescind  a  provisional  discharge,  when   the  patient  is  a  prospective  research  subject  for  a  study  conducted  by  the  study  team.     The  SOP  “Legally  Authorized  Representatives,  Children,  and  Guardians”  establishes  a   hierarchy  of  LARs  who  may  provide  consent  for  an  adult  determined  to  lack  capacity  and   other  restrictions:     1.5

Unless  the  IRB  has  waived  the  requirement  to  obtain  consent,  when  research  involves   adults  unable  to  consent,  permission  must  be  obtained  from  a  legally  authorized   representative.  Minnesota  law  does  not  specifically  address  the  issue  of  research   participation  by  incapacitated  adults.   1.5.1

Based  on  legal  advice,  the  IRB  follows  the  Minnesota  laws  on  surrogate   consent  in  health  care  to  determine  surrogate  consent  for  research   participation,  including  specifically  the  law  on  surrogate  consent  for   treatment  of  incapacitated  patients  undergoing  in-­‐patient  mental  health   treatment.    When  research  is  conducted  in  Minnesota  the  following   individuals  meet  this  definition  in  order  of  priority:   1.5.1.1

Healthcare  agent  previously  appointed  by  the  individual  through  a   health  care  power  of  attorney;  

1.5.1.2

Spouse;  

1.5.1.3

Parents;  

1.5.1.4

Adult  children;  and  

1.5.1.5

Adult  siblings.  

1.5.2

The  legally  authorized  representative  may  not  be  a  member  of  the  clinical  or   research  staff  or  an  employee  or  beneficiary  of  the  sponsor  of  the  research   project.  

1.5.3

Under  Minnesota  law,  an  incapacitated  adult  who  has  a  court  appointed   guardian  or  conservator  may  not  receive  experimental  treatment  of  any  kind   unless:  1)  a  court  first  approves  the  treatment  through  a  court  order;  or  2)  the   court’s  guardianship  order  specifically  authorizes  the  guardian  to  consent  to   research  participation  in  addition  to  medical  treatment  generally.    

1.5.4

For  research  outside  Minnesota,  a  determination  of  who  is  a  legally   authorized  representative  is  to  be  made  with  consultation  from  legal  counsel.  

   

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    Discussion:     The  introduction  of  these  policies  on  consent  and  approval  criteria  is  a  step  forward.       How  effectively  they  will  be  disseminated  and  applied  in  the  IRB  and  in  the  research   clinic  will  depend  to  a  large  extent,  however,  on  the  quality  of  new  training  initiatives.     The  University  should  remain  active  in  evaluating  the  value  of  such  tools  and  checklists   and  in  assessing  the  education  and  training  efforts  that  are  underway.     The  IRB  could  develop  rules  and  standards  to  better  guide  reviewer  decisions.   For  example,  as  currently  written,  it  appears  to  be  solely  at  the  reviewer’s  discretion  to   require  the  presence  of  a  witness  during  consent,  or  to  require  the  live  monitoring  of  a   consent  process.      The  active  use  of  consent  observation  as  a  monitoring  and   educational  tool  should  be  encouraged  and  policy  driven.       While  the  Department  of  Psychiatry  has  established  a  rule  preventing  clinician   researchers  from  being  “involved  in  the  research  consent  process”  when  the   prospective  subject  is  in  their  care,  it  is  not  clear  if  this  same  rule  extends  to   recruitment.    In  the  interest  of  preserving  voluntariness  of  consent,  clinicians  should  not   approach  their  patients  to  solicit  interest  in  their  studies.  The  IRB  should  also  consider   whether  this  rule  should  extend  beyond  Psychiatry.                            

 

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V.  Research  practices  within  the  Department  of  Psychiatry     The  External  Review  identified  a  number  of  system-­‐wide  deficiencies  in  oversight  of   research  that  had  implications  for  Psychiatry,  such  as  the  pro  forma  departmental   scientific  review  of  IRB  proposals.    Other  problems  were  specific  to  Psychiatry.   Questions  about  the  integrity  of  two  clinical  investigators,  one  of  whom  was  the   department  head,  were  at  the  core  of  concerns  by  many  faculty,  staff  members,  and   external  critics.    In  the  aftermath  of  the  Markingson  case,  and  in  the  context  of  ongoing   criticism  of  industry  sponsored  clinical  trials  in  the  Psychiatry  at  the  University  of   Minnesota,  too  little  was  done  within  the  department  to  acknowledge  the  seriousness   of  the  allegations  or  to  address  the  department’s  broader  obligations  to  support  human   subject  protection.           Observations:     Without  question  much  has  changed  within  Psychiatry  as  a  result  of  the  Advancing   Human  Research  Protections  initiative.     Following  the  External  Review,  Dr.  Charles  Schulz  stepped  down  as  Head  of  Psychiatry.   His  departure  was  a  necessary  and  more  than  simply  symbolic  event  that  was  important   to  efforts  to  rebuild  trust  in  Psychiatry.     Dr.  Mark  Paller,  Senior  Associate  Vice  President  of  the  Academic  Health  Center  was   named  Interim  Head  of  Psychiatry  and  also  charged  with  overseeing  the  implementation   effort  as  it  applied  to  the  department.    Under  his  stewardship,  Psychiatry  has  been   affirmatively  engaged  with  the  component  functions  of  Advancing  Human  Research   Protections  initiative.    While  implementation  is  incomplete,  the  design  of  new   programs,  policies,  requirements,  and  practices  reflects  the  thoughtful  and  willing   engagement  by  Psychiatry  leadership,  staff  and  faculty.           Following  a  nationwide  search,  Dr.  Sophia  Vinogradov,  formerly  Professor  and  Vice  Chair   at  UCSF,  was  named  Head  of  Psychiatry.    Her  own  research  examines  cognitive  training   in  schizophrenia  and  the  neural  underpinnings  of  the  disabling  cognitive  deficits   associated  with  serious  mental  illness.    Dr.  Vinogradov  has  announced  plans  for  a   department  wide  strategic  planning  initiative,  and  has  signaled  her  commitment  to   human  research  protections,  discussed  further  in  the  next  section,  with  plans  for  the   development  of  a  consumer  advisory  board  to  provide  “  important  viewpoints  on    

Page  20  of  25

ethical,  compassionate,  and  consumer-­‐relevant  approaches  to  all  of  the  department’s   activities.”     Dr.  Stephen  Olson  is  no  longer  actively  involved  in  clinical  trials.    Should  he  seek   permission  to  conduct  research  again,  his  request  will  be  subject  to  review  and  his  work   will  be  subject  to  special  educational,  supervisory,  and  monitoring  requirements   outlined  in  the  Work  Plan.       As  noted,  as  an  interim  measure,  the  University  has  outsourced  the  review  of  industry-­‐ sponsored  research  in  Psychiatry  to  the  Quorum  IRB.    The  CTSI  has  assumed  the   management  of  the  conduct  of  all  clinical  trials  in  Psychiatry.         An  ambitious  plan  for  competency-­‐based  training  (Appendix,  Department  of  Psychiatry     Final  Report)  in  informed  consent  has/or  is  soon  to  be  piloted  in  Psychiatry.    The  goal  of     the  Good  Clinical  Practices:  the  Informed  Consent  Process  is  to  train  staff  to:     Confidently,  ethically,  and  humanely  carry  out  all  tasks  appropriate  to  their  roles   within  the  research  team  in  the  informed  consent  process  for  regular  and  special   populations  of  participants  according  to  the  FDA  21CFR50.25  and  45CFR46.111,  ICH   GCP  principles  and  Good  Clinical  Practice  guidelines,  Minnesota  Law,  and  University   of  Minnesota  guidelines.     To  “mitigate  issues  of  therapeutic  misconception,”  the  Department  of  Psychiatry  has  developed   and  implemented  the  “Dual  Role  Consenting  Policy,”    (Appendix)  which  is  also  cross-­‐referenced   in  IRB  policy  “Research  Involving  Adults  With  Absent,  Diminished,  or  Fluctuating  Capacity  to   Consent  to  Participate  in  Research.”  The  policy  prohibits  clinicians  who  are  treating  patients   from  “being  involved  in  the  consent  process”  when  they  are  also  the  study’s  investigator.    The   policy  also  requires  patients  to  be  given  an  opportunity  to  confer  with  another  clinician  about   treatment  options  when  choosing  whether  to  take  part  in  research.    Beyond  simply  addressing   patients’  tendency  to  overestimate  the  clinical  benefit  of  research  involvement  (“the   therapeutic  misconception”),  this  policy  addresses  the  clinician-­‐investigator’s  conflicting   interests  in  serving  the  best  interest  of  the  patient  and  fulfilling  the  needs  of  the  research.      It   also  recognizes  that  patients  may  have  difficulty  declining  research  participation  when  it  is   offered/suggested  by  their  caregiver.         The  “Clinical  Research  Study  Checklist  Fairview  Behavioral  Health  Services”  seeks  to     promote  the  involvement  of  clinical  staff  in  gatekeeping  functions.  The  purpose  of  this      

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checklist  is  to  “provide  a  process  so  that  leadership  and  clinical  staff  can  provide  input     into  how  clinical  research  is  developed  and  performed  on  the  Fairview  Behavioral     Health  Services.”     Discussion:     The  Department  of  Psychiatry,  in  concert  with  other  components  of  AHRP,  has  taken   important  steps  to  address  a  number  of  problems  identified  by  the  External  Review.       The  introduction  of  new  policies  regarding  consent  and  capacity,  and  especially  the   involvement  of  Fairview  clinical  staff  in  gatekeeping  functions,  represents  genuine   progress.    The  successful  recruitment  of  a  new  Department  Head  offers  opportunities   for  the  credible  engagement  by  leadership  in  setting  new  expectations  and  new   standards  for  the  ethical  conduct  of  research.  While  some  have  expressed  frustration   with  the  pace  of  change,  for  the  first  time,  the  Department  has  completed  the  necessary   groundwork  in  policy  to  foster  improvement  in  research  protections.       Much  of  the  work  of  implementation  is  now  beginning,  and  the  key  challenge  will   involve  evaluating  the  effectiveness  and  sustainability  of  newly  introduced  requirements   and  making  necessary  refinements.     The  External  Review  recognized  the  need  for  greater  IRB  expertise  in  the  review  of     research  with  vulnerable  populations.    Psychiatry  may  choose  to  play  a  more  central     role  in  setting  standards  for  the  ethical  conduct  of  research  by  insuring  that  Psychiatry  is     well-­‐represented  on  the  IRB  and  by  working  with  the  IRB  to  develop  such  standards,  as     it  has  done  with  the  “Dual  Role”  policy.         New  policies  and  guidelines  can  be  developed  to  ensure  that  the  rights  and  welfare  of   individual  research  participants  are  not  treated  as  secondary  to  the  interests  of  research   and  researchers.    The  commitment  to  protect  psychiatric  patients  requires  an   understanding  that  some  patients  with  serious  mentally  illness  are  not  able  to  protect   their  own  interests  through  the  process  of  consent,  because  of  cognitive  impairment,   because  research  offers  care  not  otherwise  accessible,  or  because  they  have,  or  may   perceive  that  they  have,  little  or  no  freedom  to  exercise  choice.  This  is  not  to  say  that   psychiatric  patients  cannot  choose,  either  on  their  own,  or  with  input  from  others,  to   participate  in  research  and  assume  certain  risks  in  the  pursuit  of  personal  benefit  or  to   benefit  science.    But  protecting  psychiatric  subjects  requires  expert  understanding  of   subjects’  susceptibility  to  risks  associated  with  experimental  therapies,  transitions  to    

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and  from  experimental  therapy,  and  drug  free  states,  among  others.    Finally,  protecting   research  subjects  who  are  “vulnerable  to  coercion  or  undue  influence,”  under-­‐educated,   and  have  limited  access  to  healthcare,  also  means  researchers  must  recognize  that   there  may  be  a  tension  between  what  is  best  for  the  patient  and  what  best  serves   research.    Importantly,  this  conflict  exists  even  when  the  investigator  is  not  the  treating   clinician.         Even  when  prospective  subjects  are  judged  to  have  “capacity”  to  consent,  they  may     be  unable  to  fully  protect  their  interests  by  making  a  careful  and  informed  choice  about   study  enrollment.    An  institution  may  provide  additional  protections  by  setting  ethical   standards  in  policy  or  in  practice.    For  example,  an  IRB  may  determine  in  policy  that   patients  who  are  stable  and  tolerating  their  current  medication  regimen  should  not  be   enrolled  in  research  that  entails  discontinuing  that  medication,  absent  compelling   justification.    An  IRB  may  request  that  an  investigator  exclude  prospective  subjects  from   participation  in  an  experimental  drug  trial  if  they  have  never  received  standard  and   available  treatment  for  the  disorder,  again  absent  compelling  justification.    Such   “paternalism”  recognizes  the  limits  of  informed  consent.       Another  related  but  distinct  concern  is  the  fact  that  current  consent  policy  appears  to   be  silent  on  the  credentials  required  of  staff  responsible  for  discussing  and  documenting   consent  or  making  a  capacity  determination.      Further,  will  (or  how  will)  the  department   seek  to  validate  the  capacity  determinations  that  result  from  the  use  of  the     McCAT-­‐CR?    What  standards  of  care  and  monitoring  should  apply  to  transitions  to  and     from  protocol-­‐based  treatment?    How  will  the  department  leadership  respond  to  non-­‐   compliance?     The  Department  head  and  ultimately  the  IRB  will  need  to  make  a  determination  about     whether  Dr.  Olson,  or  for  that  matter  any  investigator,  may  serve  as  an  investigator  on  a     human  subjects  research  protocol.    Perhaps  more  important  than  this  decision  is   whether  the  program  for  human  subjects  protections,  as  it  operates  within  the   Department,  is  setting  necessary  standards  for  the  ethical  conduct  of  research.                

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VI.  University  Culture  and  Values     The  External  Review  faulted  the  University  of  Minnesota  for  its  past  failure  to  cultivate  a   culture  that  promoted  the  ethical  conduct  of  research,  and  advised  it  to  “signal  a  change   in  its  culture  of  human  subjects  research  by  creating  an  expectation  of  excellence,   demanding  accountability,  and  more  effectively  engaging  the  community.”      As   referenced  in  earlier  sections,  the  creation  of  the  Community  Oversight  Board  and  the   Research  Compliance  Office,  like  the  development  of  the  Hierarchy  of  Accountability   and  Statement  of  Core  Commitments,  demonstrate  an  affirmative  effort  by  the   University  to  create  structures  and  define  values  that  serve  its  commitment  to  human   research  protections.         The  ambitious  campaign  to  communicate  these  values  to  University  constituents  and   stakeholders  similarly  provides  meaningful  evidence  of  progress.    The  “Communicators   Toolkit”  for  example,  includes  the  Statement  of  Core  Commitments  in  posters  and  flyers   and  digital  formats,  and  a“  Speak  Up,  It  Matters”  poster  encourages  feedback  from   research  subjects.    The  use  of  a  research  participant  contact  card  is  intended  to   encourage  research  subjects  to  ask  questions  or  lodge  complaints;  it  also  represents  an   innovative  practice  that  underscores  the  importance  of  subject  engagement.    It  is  not   surprising  that  Research  Ethics  now  occupies  prominent  place  on  the  home  page  of  the   Office  of  the  Vice  President  for  Research.    But  the  emphasis  on  research  ethics  in  the   Medical  School  blog  describing  the  recently  appointed  head  of  Psychiatry  reflects  the   new  messaging  strategy:     Dr.  Vinogradov  is  the  right  leader  to  move  reforms  forward;  to  implement  the  highest   standards  of  ethical  research;  and  to  build  a  new  culture  of  trust  and  cooperation  as  the   department  works  to  develop  innovative  state-­‐of-­‐the-­‐art  programs  of  care  for  patients,   and  to  conduct  important  scientific  investigations  that  will  lead  to  better  outcomes  for   those  with  mental  illness.   “One  of  my  first  steps  as  the  new  Department  Head  will  be  to  build  on  the  work  of  the   implementation  team  by  creating  a  ‘consumer  advisory  group’  consisting  of  people  with   lived  experiences  of  mental  illness  and  other  key  stakeholders  from  the  community,   such  as  family  members,  advocates,  and  community  providers,“  said  Dr.  Vinogradov.  “I   will  count  on  this  advisory  group  to  provide  me  important  viewpoints  on  ethical,   compassionate,  and  consumer-­‐relevant  approaches  to  all  of  the  department’s  activities.    

 

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  The  proposal  to  gather  data  to  assess  and  track  “culture”  by  employing  an  empirically  validated   instrument,  the  Survey  of  Organization  Research  Climate,  represents  a  unique  and  potentially   valuable  method  of  measuring    attitudinal  change  in  response  to  interventions  and  to   benchmark  these  findings  against  other  institutions.     Certainly,  the  External  Review  became  part  of  a  national  dialogue  in  the  human  research   protections  community.    Dr.  Herman’s  willingness  to  participate  in  a  panel  discussion  at   PRIM&Rs  annual  meeting  in  2015  demonstrated  the  University’s  willingness  to  discuss   the  challenges  it  has  faced  and  offer  guidance  to  others.     Discussion:     The  University  has  responded  to  the  letter  and  spirit  of  the  recommendations  of  the  External   Review  and  has  undertaken  a  broad-­‐based  effort  to  affirm  and  communicate  its  commitment  to   human  research  protections,  to  accountability,  and  to  community  engagement.           While  the  benefits  of  Advancing  Human  Research  will  accrue  over  time  with  experience   and  as  the  new  processes  and  functions  evolve,  there  is  impressive  forward  movement   at  present.     The  considerable  accomplishments  of  the  many  participants  in  AHRP,  their  drive,   dedication  and  creativity,  should  be  a  source  of  pride  throughout  the  University.          

 

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